ARDS, HumanNCT05307913
PET - PEEP by EIT for Acute Respiratory Distress Syndrome Trial
A study testing EIT-guided PEEP and Table-guided PEEP in people with ARDS, Human, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study is a multicentric randomized controlled study.The objective of this study is to compare the prognosis of patients with ARDS between EIT-oriented individualized PEEP and traditional lower PEEP/FiO2 table-oriented PEEP strategy. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ARDS, Human
- What is being tested?
- EIT-guided PEEP and Table-guided PEEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 676 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2022to 10 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Intubated, mechanically ventilated patients with diagnosis of ARDS according to ARDS Berlin standard by attending doctor
Who cannot join
- Age < 18 years old and > 90 years old;
- Pregnancy;
- EIT contradictions (presence of pacemaker or automatic implantable cardioverter defibrillator);
- Severe intracranial hypertension;
- Pneumothorax, pneumomediastinum, subcutaneous emphysema or at high-risk for pneumothorax (e.g., pneumatocele, interstitial lung disease);
- Unstable hemodynamic status intorerable to lung recruitment and PEEP titration, judged by an attending intensivist; (This may be a transient criterion, since patients meeting this criterion might be included later if hemodynamics improves)
- End status of disease;
- Patients or their families refused to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: EIT-guided PEEP Titration Versus Low PEEP/FiO2 Table for ARDS: a Multicenter, Randomized, Controlled Trial
This study is a multicentric randomized controlled study.The objective of this study is to compare the prognosis of patients with ARDS between EIT-oriented individualized PEEP and traditional lower PEEP/FiO2 table-oriented PEEP strategy.
- Conditions
- ARDS, Human
- Being tested
- EIT-guided PEEP, Table-guided PEEP
- Keywords
- electrical impedance tomography, ARDS, PEEP
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIT-guided PEEPOther
PEEP setting according to EIT
Table-guided PEEPOther
PEEP setting according to the lower PEEP/FiO2 table
| Study group | Role | What they receive |
|---|---|---|
| EIT-guided PEEP | Experimental | PEEP titration by EIT Receives: Other: EIT-guided PEEP |
| Table-guided PEEP | Active comparator | PEEP selection by the lower PEEP/FiO2 table Receives: Other: Table-guided PEEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival in 28 days
Survival within 28 days from randomization
Measured: 28 days
Secondary outcomes (7)
Lenght of ICU stay
Length of hospital stay from randomization to ICU discharge
Measured: Maximum 6-months
Lenght of hospital stay
Length of hospital stay from randomization to hospital discharge
Measured: Maximum 6-months
28-day ventilator-free days
Number of days alive and out of mechanical ventilation between randomization and 28 days after randomization.
Measured: 28 days
Barotrauma
We consider as barotrauma within 7 days any pneumothorax, pneumomediastinum, subcutaneous emphysema or pneumatocele > 2cm detected on image exams between randomization and 7 days, except those judged to be clearly caused by invasive procedures.
Measured: 7 days
ICU survival
Survival at ICU discharge.
Measured: Maximum 6-months
hospital survival
Survival at hospital discharge.
Measured: Maximum 6-months
change of Sequential Organ Failure Assessment (SOFA) score
change of SOFA score within first 2 days
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start10 Apr 2022
- Primary completion27 Feb 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 676 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307913
- Sponsor's protocol ID
- PEEP by EIT for ARDS
- Status last verified
- Apr 2022
- First submitted
- 29 Dec 2021
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanchez-Piedra C, Rodriguez-Ortiz-de-Salazar B, Roca O, Prado-Galbarro FJ, Perestelo-Perez L, Sanchez-Gomez LM. Electrical impedance tomography for PEEP titration in ARDS patients: a systematic review and meta-analysis. J Clin Monit Comput. 2025 Oct;39(5):987-997. doi: 10.1007/s10877-025-01266-2. Epub 2025 Feb 26.
PubMed 40011398Wong H, Chi Y, Zhang R, Yin C, Jia J, Wang B, Liu Y, Shang Y, Wang R, Long Y, Zhao Z, He H. Multicentre, parallel, open-label, two-arm, randomised controlled trial on the prognosis of electrical impedance tomography-guided versus low PEEP/FiO2 table-guided PEEP setting: a trial protocol. BMJ Open. 2024 Feb 1;14(2):e080828. doi: 10.1136/bmjopen-2023-080828.
PubMed 38307528
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EIT-guided PEEP Titration Versus Low PEEP/FiO2 Table for ARDS: a Multicenter, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05307913
- Acronym / sponsor ID
- PEEP by EIT for ARDS
- Conditions
- ARDS, Human
- Keywords
- electrical impedance tomography, ARDS, PEEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 676 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicentric randomized controlled study.The objective of this study is to compare the prognosis of patients with ARDS between EIT-oriented individualized PEEP and traditional lower PEEP/FiO2 table-oriented PEEP strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EIT-guided PEEP | Experimental | Other: EIT-guided PEEPPEEP titration by EIT |
| Table-guided PEEP | Active comparator | Other: Table-guided PEEPPEEP selection by the lower PEEP/FiO2 table |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Intubated, mechanically ventilated patients with diagnosis of ARDS according to ARDS Berlin standard by attending doctor
Key exclusion criteria (8 listed)
- Age < 18 years old and > 90 years old;
- Pregnancy;
- EIT contradictions (presence of pacemaker or automatic implantable cardioverter defibrillator);
- Severe intracranial hypertension;
- Pneumothorax, pneumomediastinum, subcutaneous emphysema or at high-risk for pneumothorax (e.g., pneumatocele, interstitial lung disease);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EIT-guided PEEPPEEP setting according to EIT | Other | EIT-guided PEEP |
| Table-guided PEEPPEEP setting according to the lower PEEP/FiO2 table | Other | Table-guided PEEP |
Primary outcome
Survival in 28 days
Time frame: 28 days
Survival within 28 days from randomization
7 secondary outcomes
Lenght of ICU stay
Time frame: Maximum 6-months
Lenght of hospital stay
Time frame: Maximum 6-months
28-day ventilator-free days
Time frame: 28 days
Barotrauma
Time frame: 7 days
ICU survival
Time frame: Maximum 6-months
hospital survival
Time frame: Maximum 6-months
change of Sequential Organ Failure Assessment (SOFA) score
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Derived from this study: PubMed 40011398Sanchez-Piedra C, Rodriguez-Ortiz-de-Salazar B, Roca O, Prado-Galbarro FJ, Perestelo-Perez L, Sanchez-Gomez LM. Electrical impedance tomography for PEEP titration in ARDS patients: a systematic review and meta-analysis. J Clin Monit Comput. 2025 Oct;39(5):987-997. doi: 10.1007/s10877-025-01266-2. Epub 2025 Feb 26.
- Derived from this study: PubMed 38307528Wong H, Chi Y, Zhang R, Yin C, Jia J, Wang B, Liu Y, Shang Y, Wang R, Long Y, Zhao Z, He H. Multicentre, parallel, open-label, two-arm, randomised controlled trial on the prognosis of electrical impedance tomography-guided versus low PEEP/FiO2 table-guided PEEP setting: a trial protocol. BMJ Open. 2024 Feb 1;14(2):e080828. doi: 10.1136/bmjopen-2023-080828.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EIT-guided PEEP and Table-guided PEEP in people with ARDS, Human, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival in 28 days (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05307913, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.